Section § 4128

Explanation

This law allows specialized hospital pharmacies to prepare medications for patients when these hospitals are under the same ownership and within 75 miles of each other. They can repack and barcode large amounts of medication into smaller, single-dose packages specifically for use within these hospitals. The definition of "common ownership" means that the ownership details for these pharmacies must match with those filed with the relevant board.

(a)CA Business & Professions Code § 4128(a) Notwithstanding Section 4029, a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other:
(1)CA Business & Professions Code § 4128(a)(1) Preparing unit dose packages for single administration to inpatients from bulk containers, if each unit dose package is barcoded pursuant to Section 4128.4.
(2)CA Business & Professions Code § 4128(a)(2) Preparing sterile compounded unit dose drugs for administration to inpatients, if each compounded unit dose drug is barcoded pursuant to Section 4128.4.
(3)CA Business & Professions Code § 4128(a)(3) Preparing compounded unit dose drugs for administration to inpatients, if each unit dose package is barcoded pursuant to Section 4128.4.
(b)CA Business & Professions Code § 4128(b) For purposes of this article, “common ownership” means that the ownership information on file with the board pursuant to Section 4201 for the licensed pharmacy is consistent with the ownership information on file with the board for the other licensed pharmacy or pharmacies for purposes of preparing medications pursuant to this section.

Section § 4128.2

Explanation

This law explains that centralized hospital packaging pharmacies in California need a special license from the board in addition to their regular pharmacy license. To get this specialty license, they must apply using specific board-provided forms and pass an inspection to ensure they follow all rules. This license is only available to hospital pharmacies and has to be renewed every year, requiring another inspection. The license is also not transferrable to another pharmacy. These rules will kick in starting January 1, 2025.

(a)CA Business & Professions Code § 4128.2(a) In addition to the pharmacy license requirement described in Section 4110, a centralized hospital packaging pharmacy shall obtain a specialty license from the board prior to engaging in the functions described in Section 4128.
(b)CA Business & Professions Code § 4128.2(b) An applicant seeking a specialty license pursuant to this article shall apply to the board on forms established by the board.
(c)CA Business & Professions Code § 4128.2(c) Before issuing the specialty license, the board shall inspect the pharmacy and ensure that the pharmacy is in compliance with this article and regulations established by the board.
(d)CA Business & Professions Code § 4128.2(d) A license to perform the functions described in Section 4128 may only be issued to a pharmacy that is licensed by the board as a hospital pharmacy.
(e)CA Business & Professions Code § 4128.2(e) A license issued pursuant to this article shall be renewed annually and is not transferrable.
(f)CA Business & Professions Code § 4128.2(f) An applicant seeking renewal of a specialty license shall apply to the board on forms established by the board.
(g)CA Business & Professions Code § 4128.2(g) A license to perform the functions described in Section 4128 shall not be renewed until the pharmacy has been inspected by the board and found to be in compliance with this article and regulations established by the board.
(h)CA Business & Professions Code § 4128.2(h) This section shall become operative on January 1, 2025.

Section § 4128.3

Explanation

This law allows a centralized hospital pharmacy to prepare and store a limited amount of unit dose medications before receiving specific prescriptions. The goal is to ensure the hospital can continuously provide care to its patients, based on past prescription patterns for these patients.

A centralized hospital packaging pharmacy may prepare and store a limited quantity of the unit dose drugs authorized by Section 4128 in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a documented history of prescriptions for that patient population.

Section § 4128.4

Explanation

This law requires any single-use medication made by a hospital's central pharmacy to have a barcode that healthcare staff can scan at a patient's bedside. This ensures they give the right medication to the right patient in the right amount and way. The software used for scanning, called barcode medication administration software, helps prevent medication errors by checking the information against the patient's electronic medical record.

(a)CA Business & Professions Code § 4128.4(a)  Any unit dose medication produced by a centralized hospital packaging pharmacy shall be barcoded to be machine readable at the inpatient’s bedside using barcode medication administration software.
(b)CA Business & Professions Code § 4128.4(b) The barcode medication administration software shall permit health care practitioners to ensure that, before a medication is administered to an inpatient, it is the right medication, for the right inpatient, in the right dose, and via the right route of administration. The software shall verify that the medication satisfies these criteria by reading the barcode on the medication and comparing the information retrieved to the electronic medical record of the inpatient.
(c)CA Business & Professions Code § 4128.4(c)  For purposes of this section, “barcode medication administration software” means a computerized system designed to prevent medication errors in health care settings.

Section § 4128.5

Explanation

This law requires that labels for unit dose medications made by a centralized hospital packaging pharmacy include specific details. These details must include the preparation date, expiration date, name and quantity of the drug, storage needs, the lot or control number, and the pharmacy's name. Additionally, pharmacists should be able to use the lot or control number for tracking purposes to find information about the drug's ingredients, their expiration dates, and the National Drug Code number.

(a)CA Business & Professions Code § 4128.5(a) Any label for each unit dose medication produced by a centralized hospital packaging pharmacy shall display a human-readable label that contains all of the following:
(1)CA Business & Professions Code § 4128.5(a)(1) The date that the medication was prepared.
(2)CA Business & Professions Code § 4128.5(a)(2) The beyond-use date.
(3)CA Business & Professions Code § 4128.5(a)(3) The established name of the drug.
(4)CA Business & Professions Code § 4128.5(a)(4) The quantity of each active ingredient.
(5)CA Business & Professions Code § 4128.5(a)(5) Special storage or handling requirements.
(6)CA Business & Professions Code § 4128.5(a)(6) The lot number or control number assigned by the centralized hospital packaging pharmacy.
(7)CA Business & Professions Code § 4128.5(a)(7) The name of the centralized hospital packaging pharmacy.
(b)CA Business & Professions Code § 4128.5(b) For quality control and investigative purposes, a pharmacist shall be able to retrieve all of the following information using the lot number or control number described in subdivision (a):
(1)CA Business & Professions Code § 4128.5(b)(1) The components used in the drug product.
(2)CA Business & Professions Code § 4128.5(b)(2) The expiration date of each of the drug’s components.
(3)CA Business & Professions Code § 4128.5(b)(3) The National Drug Code Directory number.

Section § 4128.6

Explanation

This law states that all tasks related to compounding and packaging medications must only be done in a hospital pharmacy that has the proper license. The pharmacy must follow all relevant federal and state laws and rules, especially those for making compounded or sterile medications when necessary.

All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile compounding.

Section § 4128.7

Explanation

This law says that a centralized hospital packaging pharmacy and its pharmacists must ensure that any single-dose medication they prepare is safe, effective, of high quality, and accurately labeled.

A centralized hospital packaging pharmacy and the pharmacists working in the pharmacy shall be responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy.